OdneFill Tips 25mm

GUDID 07649988629341

OdneFill tip 25 mm, 10 pieces, not sterile, for application of OdneFill endodontic obturation material

Odne AG

Dental material injection cannula, single-use
Primary Device ID07649988629341
NIH Device Record Key350c7df5-fcdd-49e0-a11d-2f2cce61ebba
Commercial Distribution StatusIn Commercial Distribution
Brand NameOdneFill Tips 25mm
Version Model NumberE-8020
Company DUNS480237899
Company NameOdne AG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107649988629341 [Primary]

FDA Product Code

EIYInstrument, Filling, Plastic, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-11
Device Publish Date2025-09-03

Devices Manufactured by Odne AG

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07649988629341 - OdneFill Tips 25mm2025-09-11OdneFill tip 25 mm, 10 pieces, not sterile, for application of OdneFill endodontic obturation material
07649988629341 - OdneFill Tips 25mm2025-09-11 OdneFill tip 25 mm, 10 pieces, not sterile, for application of OdneFill endodontic obturation material
07649988156632 - OdneClean2024-12-06 1 OdneClean Device containing hose, metal rod holder, handpiece, multiple connection hoses, hose for disinfection, plug and cabl
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07649988072475 - OdneFill Tip2024-02-09 OdneFill tip, 10 pieces, not sterile, for application of OdneFill endodontic obturation material
07649988156694 - OdneCure2024-02-09 1 OdneCure Root Canal Cleaning Device consisting of Charging stand, 2 batteries, body of the lamp, packaged with Cable, Plug, 50
07649988156649 - OdneFill2024-02-08 OdneFill Endodontic Filler, 10x 0.2 ml, Box of 10 syringes. Hydrophilic, radiopaque, light-curable endodontic sealer, consisting

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